Adverse Event Reporting.

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Presentation transcript:

Adverse Event Reporting

Reporting Adverse Events Adverse Events (AEs) are “. . . any untoward medical occurrence in a subject that was not previously identified which does not necessarily have a causal relationship to the study drug…” Events existing prior to randomization should not be reported as AEs, unless there is a change in severity Pre-existing conditions that are discovered after randomization are not adverse events. These should be documented as medical history. Abnormal lab values that are considered to be clinical significant by the site investigator are adverse events

Reporting Adverse Events Adverse Events are reported on Form 10: Adverse Event 1 AE per CRF Report the diagnosis, not the symptoms: Fever, cough, chest pain, crackles = pneumonia Avoid abbreviations/colloquialisms

Reporting Adverse Events Death, surgery, intubation, etc. are not adverse events. They are outcomes of adverse events All AEs will be centrally coded verbatim using MedDRA AEs that can’t be coded will be queried

Reporting Adverse Events From Randomization through Day 7: Report all AEs From Day 7 through EOS: Report only SAEs and PAAEs (Potentially Associated Adverse Events)

Reporting Adverse Events Serious Adverse Events are: Fatal, Life-Threatening, Result in hospitalization/prolongation of hospitalization- excluding optional, pre- planned surgery Result in disability/congenital anomaly, or Require intervention to prevent permanent impairment or damage

Data Entry Time Lines for AEs Non-serious AEs must be entered and submitted into WebDCUTM within 5 days of data collection. SAEs and PAAEs must be entered and submitted into WebDCUTM within 24 hours of discovery

Reporting SAEs/PAAEs SAEs/PAAEs require additional information to be submitted on the AE CRF: 1. Detailed description of the event 2. Relevant tests/laboratory data 3. Relevant history and pre-existing conditions 4. Concomitant meds

Reporting SAEs/PAAEs These narratives assist the Medical Safety Monitor in reviewing the event Narratives are pre-populated into the MedWatch form, if expedited reporting is required Do not identify any subject, physician, or institution by name.

Reporting SAEs/PAAEs Spoke data enters and submits AE CRF into WebDCUTM Automatic e-mail notification to Project Manager (PM). PM reviews narrative - - If AE data is sufficient, an automatic email notification will be sent to the Medical Safety Monitor (MSM) MSM blindly reviews the event and indicates whether the event is serious, unexpected, and study drug related PM closes review process

MedWatch Reports FDA requires expedited reporting for AEs that are serious, unexpected, and study drug related If the MSM determines that the SAE/PAAE is serious, unexpected, and related to study drug, WebDCUTM generates an pre-populated MedWatch form and sends an automatic email notification to the spoke coordinator.

MedWatch Reports Spoke staff completes the MedWatch The PM submits MedWatch to FDA The PM notifies hubs of MedWatch posting on WebDCU Spoke PIs are responsible for reporting the SAE to their IRB according to local requirements.

MedWatch Reports Fatal or life threatening SAEs: - Initial report due within 7 days of discovery - Complete report due within 15 days of discovery Non-fatal and non-life threatening SAEs: - Initial report due within 15 days of discovery Follow Up Reporting - PI responsible for obtaining any follow-up information and submitting that data into WebDCUTM as soon as it becomes available.

Pop Quiz!

How do you report a SAE? Call the ProTECT Hotline Call the ProTECT hotline and data enter the AE CRF Data enter the AE CRF Data enter and submit the AE CRF

What are the timelines for submission of SAE and PAAE data? 3 days from first knowledge of the event 5 days from first knowledge of the event 24 hours from first knowledge of the event 48 hours from first knowledge of the event

Which AEs must be reported on a MedWatch? Serious AEs Serious AEs that result in death Serious AEs that are study related Serious AEs that are study related and unexpected

True or False: ‘Death’ is a valid adverse event name